DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The disclosure is objected to because of the following informalities:
In the specification, page 1, Related Applications Section, starting in line 5 of page 1 and ending on page 2, line 9, the bibliographical information needs to be updated to disclose U.S. Patent numbers. The examiner of record reviewed all the documents in this section to verify support for this application and notice that, with the exception of Application serial no. 15/017007 [not allowed], all non-provisional applications listed have been allowed and are now U.S. patents. Accordingly, this section must be updated to reflect the latest and most updated bibliographical information possible. Appropriate correction is required.
Claim Rejections - 35 USC § 112 [first paragraph]
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 99-115 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In relation to independent claim 99 [and dependent claims], the specification of this application does not disclose or describe anywhere “a cannula assembly configured to couple to the housing and including a cannula configured with a sharpened distal end forming a cylindrical scalpel configured to rotate to incise skin pixels.” Actually, the phrase “cannula assembly” is not found in the specification of this application. Since the phrase “cannula assembly” is not defined in the specification, it is impossible to establish a structural relationship between the undefined “cannula assembly”, the housing, and the cannula configured with a sharpened distal end forming a cylindrical scalpel configured to rotate. Conclusively, claims 99-114 have no support in the specification of this application. Appropriate correction is required.
Claims not entitled to benefit: as explained above, the phrase a “cannula assembly” is not disclosed in the specification of this application. Additionally, the examiner searched the phrase in question in all the provisional and non-provisional applications listed in the Related Application section of this application. The phrase a “cannula assembly” is not disclosed in any of the applications listed. Claims 99-114 are not entitled to the benefit of the filing date of the prior application(s) because the prior application(s) does not disclose the claimed invention in the manner required by 35 U.S.C. 112(a). Therefore, the effective filing date of the claim(s) is the filing date of the present application.
Claim Rejections - 35 USC § 112 [second paragraph]
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 107 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In relation to claim 107 [and dependent claim 108], The term "the first end cap" has proper antecedent basis in claim 106. The term "a depth guide" is properly introduced. However, the term "the at least one cannula" lacks clear antecedent basis. Claim 101 introduces "at least one scalpet" within "the cannula", but not "at least one cannula". Claim 99 introduces "a cannula". This creates an ambiguity; therefore, the claim is indefinite because it fails to identify "the at least one cannula" with reasonable certainty. The term lacks proper antecedent basis in the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 99, 100, 101, 109, 110, 111, and 112 are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. (US 2007/0293884A9; hereinafter “Cole”) in view of Hall et al. (US 2012/0271320A1; hereinafter “Hall”).
Independent claim 99 recites a device comprising:
(a) a handpiece configured to couple to a housing including a chamber;
(b) a cannula assembly configured to couple to the housing and including
(c) a cannula configured with a sharpened distal end forming a cylindrical scalpel
(d) configured to rotate to incise skin pixels.
In relation to independent claim 99, Cole discloses a device for follicular dissection that comprises a handpiece (Powered Follicular Isolation Device or PFID), a housing, a cannula (punch), and a drive mechanism for rotating the cannula. Specifically, Cole teaches:
a handpiece (PFID):
"In various embodiments, at least one punch may be coupled to a Powered Follicular Isolation Device (PFID)." (paragraph [0058])
a housing:
"A main drive section 1100 may consist of a power source (not shown), a main motion source 1104, and housing 1105." (paragraph [0121])
a cylindrical cannula/scalpel (punch) with a sharpened distal end:
"In a particular embodiment, a punch may have a substantially cylindrical shape with an outside
diameter, an inside diameter and a longitudinal length... one or more edges may be used for dissecting tissue and referred to as a cutting edge and/or cutting edges." (paragraph [0057])
rotation to incise skin:
"When punch 800 is rotated in the direction of the primary cutting edge 803, primary cutting edge 803 may incise skin ahead of it with little force." (paragraph [0100])
Cole does not explicitly disclose a chamber for collecting incised skin pixels. Cole's punch is designed to hold the graft within the punch itself: "a tissue graft (not shown) may be held within punch 10, due to a gradual increase in diameter of inner surface 11" (paragraph [0063]). However, Hall discloses a skin grafting device that includes a housing with a collection chamber for harvested tissue particles. Hall teaches:
a housing with a collection container:
"a device for obtaining a plurality of skin tissue particles for use in skin grafting, the device comprising: a processor configured to process skin tissue into a plurality of skin tissue particles; and a container configured to retain the plurality of skin tissue particles..." (paragraph [0021])
Vacuum-assisted collection:
"During operation of this embodiment, the skin tissue can be excised and transferred by vacuum to a removable/disposable collection canister or container." (paragraph [0042])
Based on the above comments, a person of ordinary skill in the art, seeking to improve the
efficiency of the tissue harvesting process in Cole's device, would have been motivated to incorporate a collection chamber as taught by Hall. The collection of multiple tissue samples without needing to remove each one individually from the punch would be a logical and desirable improvement. It would be obvious to modify Cole's device to include a chamber into which the harvested grafts are deposited, as this would streamline the procedure and reduce manual handling of the grafts. Therefore, the combination of Cole and Hall renders claim 99 obvious.
In relation to claim 100, this claim recites the device of claim 99, comprising a drive shaft configured to couple to the handpiece and the cannula assembly. Cole discloses a drive shaft that couples the handpiece (PFID) to the cannula (punch). Cole teaches:
a drive shaft (output shaft):
"punch 1110 coupled to PFID 1108 may be extended and/or retracted by a linear solenoid actuator 1111... Fork 1115 may be coupled to a collar 1125 fixed to an output shaft 1119." ([0123]) and "Rotary motion delivered by electromotor 1161 at a certain speed may be transferred to punch 1160 directly... output shaft 1169" (paragraph [0125])
As established for claim 99, the combination of Cole and Hall teaches all the elements of claim 99. Since Cole explicitly discloses a drive shaft coupling the handpiece and cannula assembly, claim 100 is also obvious over the combination of Cole and Hall.
In relation to claim 101, this claim recites the device of claim 99, wherein the cannula comprises at least one scalpet. The term "scalpet" is defined in the specification of the application under examination as a small, sharp, cutting instrument. Cole's punch, with its sharpened cutting edge, functions as a scalpel. The combination of Cole and Hall teaches all the elements of claim 99. The cannula of Cole, being a cylindrical punch with a cutting edge, is a type of scalpel. Therefore, claim 101 is obvious over the combination of Cole and Hall.
In relation to claims 109, 110, 111, and 112, claim 109 recites the device of claim 100, wherein the chamber is configured as a mincing chamber to mince the skin pixels; claim 110 recites the device of claim 109, comprising a mincing blade configured to removably couple to the drive shaft; claim 111 recites the device of claim 110, wherein the mincing blade is configured to replace the cannula assembly; and claim 112 recites the device of claim 110, comprising a second end cap configured to
removably couple to the second end of the chamber.
Cole does not teach a mincing chamber or mincing blade. However, Hall discloses a device
that both harvests and minces tissue:
Mincing processor:
Hall describes a "processor configured to process skin tissue into a plurality of skin tissue particles... wherein the processor comprises a first cutting surface configured to penetrate skin tissue at a donor site and a second cutting surface that rotates." (paragraph [0021])
Mincing blades:
Hall also discloses a "disposable, single-use skin mincer... compris[ing] two contra-rotating blades which are operated by rotating the handle, which grind the donor skin tissue into small particles." (paragraph [0043])
Based on the above comments, a person of ordinary skill in the art would have been motivated to combine the harvesting capabilities of Cole's device with the mincing functionality of Hall's device to create a single, integrated instrument that can both harvest and process tissue. This would have eliminated the need for a separate mincing step, making the overall procedure more efficient. It would be obvious to incorporate a mincing blade, driven by the same drive shaft as the harvesting cannula, into the collection chamber. The ability to replace the cannula with a mincing blade, and to cap the chamber for the mincing process, would have been logical design choices to facilitate this integrated functionality. Therefore, the combination of Cole and Hall renders claims 109, 110, 111, and 112 obvious.
Claims 102, 103, 104, 105, 106, 107, 108, 113, 114, and 115 are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. (US 2007/0293884A9; hereinafter “Cole”) in view of Hall et al. (US 2012/0271320A1; hereinafter “Hall”), as discussed above, and in further view of Anderson et al. (US 2015/0216545A1; hereinafter “Anderson”).
In relation to claim 102, this claim recites the device of claim 99, wherein the chamber comprises a first end and a second end, wherein the handpiece is configured to removably couple to the first end and the cannula assembly is configured to removably couple to the second end. As established for claim 99, Cole does not explicitly teach a chamber with removable ends. However, Anderson discloses a tissue harvesting apparatus with a chamber that has a removable cap:
Removable cap on chamber:
"The chamber 240 can be provided with a removable cap 320, or the like, to facilitate access to the interior of the chamber and removal of MTCs 210 that may be trapped or retained by the filter arrangement 250." (paragraph [0046])
Based on the above comments, a person of ordinary skill in the art would have found it obvious to make the collection chamber of the combined Cole/Hall device with removable ends, as taught by Anderson, to allow for easy access to and removal of the collected tissue. This would have been a simple and logical design choice for a reusable medical device. Therefore, the combination of Cole, Hall, and Anderson renders claim 102 obvious.
In relation to claims 103, 104, and 105, this claim recites the device of claim 101, wherein the cannula is configured to pass the incised skin pixels to the chamber which is configured as a collection chamber; claim 104 recites the device of claim 103, wherein the housing includes a vacuum port
configured to couple a vacuum to at least one of the chamber and the cannula; claim 105 recites the device of claim 104, wherein the vacuum is configured to pull the skin pixels into the chamber via the cannula.
Cole does not teach a collection chamber or the use of a vacuum to transport tissue. However, Hall explicitly teaches these features:
collection chamber and vacuum port:
Hall discloses a "housing configured to receive the dressing, wherein the housing comprises a first aperture configured to be coupled to a vacuum source" (paragraph [0016]) and a "container configured to retain the plurality of skin tissue particles" (paragraph [0021]).
vacuum to pull tissue:
Hall teaches that "[t]he operation of low pressure source 116 can cause air to flow... and draw the harvest site toward needles 130. Skin tissue from the harvest site can be drawn into needles 130 and removed from the harvest site." ([0034]) and "the skin tissue can be excised and transferred by vacuum to a removable/disposable collection canister or container." (paragraph [0042])
Based on the above comments, as stated for claim 99, a person of ordinary skill in the art would have been motivated to add a vacuum-assisted collection system to Cole's device to improve efficiency. The use of a vacuum to transport harvested tissue into a collection chamber is a known and effective technique, as demonstrated by Hall. It would be an obvious modification to Cole's device to include a vacuum port and a collection chamber to automate the collection of the incised tissue. Therefore, the combination of Cole and Hall renders claims 103, 104, and 105 obvious.
In relation to claims 106, 107, and 108, claim 106 recites the device of claim 102 comprising a first end cap configured to removably couple to the second end of the chamber; claim 107 recites the device of claim 106, wherein the first end cap includes a depth guide configured to control a depth of penetration of the at least one cannula into tissue; and claim 108 recites the device of claim 107, wherein a length of the depth guide is configured to control the depth, wherein the length is selectable from a plurality of lengths.
Cole teaches a variety of adjustable depth guides for controlling the penetration of the
punch:
adjustable depth guides:
Cole discloses multiple mechanisms for depth control, including a "depth marker shoulder" (paragraph [0111]), a "sliding ring" (paragraph [0110]), and a "depth stop 1037 with a sliding ring collar 1038 and handle 1035 on a barrel 1037" (paragraph [0116]).
Anderson teaches a removable cap on the chamber:
removable cap:
"[t]he chamber 240 can be provided with a removable cap 320..." (paragraph [0046]).
Based on the above comments, it would have been obvious to a person of ordinary skill in the art to combine the depth control features of Cole with the removable chamber cap of Anderson. An end cap is a suitable location for a depth guide, and making it removable allows for easy cleaning and access to the chamber. The combination of these features is a logical and straightforward design choice. Therefore, the combination of Cole and Anderson renders claims 106, 107, and 108 obvious.
In relation to claim 113, this claim recites the device of claim 112, wherein the second end cap is configured to couple to the second end of the chamber instead of the first end cap. As established for claims 109-112, the combination of Cole and Hall teaches a device with a harvesting cannula that can be replaced with a mincing blade, and a chamber that can be capped for mincing. Anderson teaches the use of a removable cap on a collection chamber ([0046]). It is a matter of simple design choice to have interchangeable end caps for different functions. A person of ordinary skill in the art, when designing a device with both harvesting and mincing capabilities, would have found it obvious to use different end caps for each function: one with a depth guide for harvesting (as in claims 106-108) and a different, sealed end cap for the mincing operation. The ability to swap these caps would have been an inherent and logical feature of such a modular design. Therefore, the combination of Cole, Hall, and Anderson renders claim 113 obvious.
In relation to claim 114 and 115, claim 114 recites the device of claim 112, wherein the second end cap includes a fitting plug; claim 115 recite the device of claim 114, wherein the fitting plug is configured to receive a syringe barrel. While Cole, Hall, and Anderson do not explicitly disclose an end cap with a fitting plug for a syringe, this is a well-known and common feature in medical devices for the purpose of introducing or extracting fluids or tissues. A person of ordinary skill in the art, when designing a device for collecting and processing tissue, would have found it obvious to include a port or fitting on the collection/mincing chamber to allow for the easy extraction of the processed tissue, for example, with a syringe. This would have been a simple and logical modification to facilitate the handling and application of the minced tissue. The use of a standard fitting, such as a Luer lock or a simple plug that can be punctured by a syringe, is a common design practice in the medical field. Therefore, adding a fitting plug to the end cap for use with a syringe would be an obvious design
choice to a person of ordinary skill in the art, and claims 114 and 115 are obvious over the
combination of Cole, Hall, and Anderson.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783